Sr. CMC Regulatory Affairs Manager, Cell/Gene Therapy

Job Description

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

 

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

 

This position is based in Westborough, Massachusetts. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

 

Purpose and Scope:

Responsible for developing submission plans for assigned projects and provides input for RA strategy. Identifies and collects data required for registration packages, often including initial IND submissions for later stage development products. Takes responsibility for the development and implementation of regulatory processes within the department. Has expert knowledge in CMC and the ability to influence decision-making for manufacturing processes for CMC strategies for multiple formulation types, analytical methods and drug stability.

 

Essential Job Responsibilities:

• Independently manages complex technical documents for preparation, review and submission to global regulatory agencies. Prepares INDs & NDAs, amendments & supplements, as well as responses to questions from regulatory agencies. Prepares and/or reviews summary tables of data from research and manufacturing reports, without direct supervision.
• Develops strategies for new assignments having less-defined regulatory frameworks with management oversight. Executes regulatory strategies with management guidance.
• Regularly interacts with senior management within areas of responsibility.
• Establishes rapport with FDA review staff and interacts regularly including negotiations in new areas. Participates in FDA meetings and manages the planning process.
• Advises global and local teams on regulatory requirements. Interprets and ensures compliance with applicable FDA/ICH regulations.
• Assists with coordination and ongoing training of Regulatory Affairs staff. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidelines. Provides CMC guidance for drug products as requested.
• Interacts with international marketing staff to define the most appropriate regulatory strategies to utilize in international product registrations, both in original submissions and to support existing registrations.
• Independently participates in promotional review for therapeutic area as needed.
• Interacts with other companies such as contract manufacturers, other Astellas subsidiaries, and Astellas Japan.
• May be involved in evaluation, review and preparation of DMF submissions from Japan, and maintenance of the DMF procedures.

Quantitative Dimensions:

Maintains all assigned projects as compliant with regulations and guidelines. Addresses complex and diverse problems with decision making that impacts multiple projects, functions and/or therapeutic areas. Actively identifies, escalates and advocates for the optimal solution while informing the necessary audience of the benefits and drawbacks of each possibility.

Interpreting federal regulations and guidance and the communication to RAQA and the project teams. Balancing multiple projects with conflicting timelines. Developing familiarity with all aspects of drug development. Maintaining working relationship with FDA while still promoting the company position.

 

Organizational Context:

The Senior Manager of Regulatory Affairs will report to the Associate Director of Regulatory Affairs CMC who reports to the Senior Director of Regulatory Affairs, a direct report of the Vice President of Regulatory Affairs. The Senior Manager of Regulatory Affairs CMC will work closely with peers in the regional Regulatory Affairs group, including the Regulatory Affairs liaisons and Regulatory Affairs Latin America.

Location(s)MA, Westborough
Requirements

Qualifications:

Required

• Bachelor’s degree in scientific or related discipline.
• At least seven years previous industry experience; four years in RA.
• Expert level of scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development having technical complexity.
• Recognized as skilled in an aspect of pharmaceutical drug development, with RA skills in focus area.
• Full knowledge of FDA and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
• Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to others in the department as needed.
• Proven ability to prioritize and multi-task with minimal supervision based on interactions with project ream members.
• Excellent written and oral communication skills, with writing ability to meet regulatory requirements and standards.
• Ability to communicate effectively and maintain effective working relationships. Must be able to positively influence department staff and other Astellas groups.
• High integrity with respect to maintenance of proprietary, confidential information.
• Excellent computer literacy.

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

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